Unethical Drug Trials,
But Health Activists Say
That Is Not Enough.
Who Will Pay for
Prescription Drugs in 2021?
Pharmaceutical Industry
& Technology Transfer agencies in India
PRICE CONTROL MECHANISM
w w w . p h a r m a l e a d e r s . c o . i n
TM
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Aamir Raises Revolt Against Branded Formulations, Pushes for Generics Medicines!
IS AAMIR KHAN A NEW MESSIAH OF DEPRIVED INDIA?
Can India Operate on a Chttorgarh Model?
The author is CEO , Natco Pharma.
The views expressed are personal.
24
26
22
6
25

Indian Pharma Brand : The Emerging Super power
he Theme of this that place their interests over the interests of the Nation. Corruption is the
year T 's Summi t is root causes of India's backwardness. The damage caused by corruption “ I n d i a n P h a rma on the country's economy and progress is unimaginable.
Brand : The Emerging
Super power”. India is The last decade has seen India emerge stronger on the world map,
poised to be the worlds next especially during the global financial meltdown when the country
superpower with sound and weathered the crisis much to the admiration of the world. India today
transparent financial system, stands poised at the threshold of change. India, today, has emerged as
flourishing IT industry and a one of the decisive nations shaping the contours of the world economy.
well-regulated stock market Consistently charting a growth path over the last few years, Brand India
.It has been active politically is an idea whose time has truly arrived. Today, the triumph of Brand India
and economically in the past is visible in almost all fields. With some aggressive cross-border
decade as well. Its core acquisitions, India has been rewriting the global business equations;
i n s t i t u t i o n s f r o m India has established its leadership in IT and knowledge-based
independent judiciary and industries globally and has the fastest growing population of workers and
free press to military are consumers. With huge investments in infrastructure development on the
secured by its more than half anvil, India today is a preferred investment destination. It has one of the
century old roots. India is on world's most rapidly growing markets, and today, Indian products and
the verge of becoming a services are recognised for their quality all over the world. (1.22 billion)
permanent member of the people is the second most populous country in the world, while China is
Eidtorial
United Nations Security Council. Its scientists are planning to launch a on the top with over 1,350,044,605 (1.35 billion) people. The figures
moon probe. By putting all theses aspects together, one may be amazed show that India represents almost 17.31% of the world's population,
that India is already in the race for becoming the next super power. which means one out of six people on this planet live in India. India is
predicted to have more than 1.53 billion people by the end of 2030. More
The question that come to my mind as I interact with people is that of a than 50% of India's current population is below the age of 25 and over
mixed reactions, which to some extent, cant be underestimated. 65% below the age of 35. This means the youth will form a majority chunk
in decision making.
Is India a Poor Country or Emerging Superpower?
The Indian economy has continuously recorded high growth rates and
India, along with China, is the fastest emerging economy in the world. It is has become an attractive destination for investments. Today India is
the fourth largest global economy looking from the purchasing power among the most attractive destinations globally, for investments and
parity angle and its large domestic market kept it insulated from the business and FDI had increased over the last few years. India's
recent depression in Western economies. Few years ago, Goldman economic growth is expected to remain robust in 2012 and 2013, despite
Sachs predicted that India's GDP would overtake France and Italy by likely headwind of double-dip recessions in Europe and the US,
2020, Germany, UK and Russia by 2025 and Japan by 2035, making it according to a United Nations' annual economic report - World Economic
the third largest economy of the world, behind the US and China. Most Situation and Prospects 2012. The Indian economy is expected to grow
economists see India as an emerging economic superpower and between 7.7 per cent and 7.9 per cent this year, as per the report.
expected it to play a major role in the global economy in the 21st century.
Being an economic power makes a country a global power. But Indians
should keep one thing in mind, and that is that India has to compete with India is the second most preferred destination for foreign investors, The
China and from the looks of it now China is deemed to be the winner. But wealth of high net worth individuals (HNIs) in India, is set to grow by a
India can move ahead. It has to develop its infrastructure and create an compounded annual growth rate (CAGR) of 23 per cent over the next
efficient and transparent administration. Communal distrust should be four years and will touch a staggering Rs 249 trillion (US$ 5.05 trillion).
eliminated and so should be right wing parties which encourage it. If India's Private Sector accounts for 75 percent of its GDP. Private sector
these problems can be taken into account and solved then India can investment has responded vigorously to the Government policy of
definitely join the global power elite. promoting competition, removing policy distortions and hurdles, and
improving access to factors of production such as technology and
My main concern is how India will construct a sustainable and capital. With domestic industry developing an increasingly global focus,
distinct identity that reflects the country's great diversity. I hope the Indian corporate sector has expanded capacity and upgraded
India will follow its own road and not simply create a facade resembling technology. Simultaneously, it has been clocking higher sales and
Western modernity. Throughout history, India has managed to absorb profits. The regulatory framework India has made sweeping reforms in
foreign elements into its culture and express them in its own language; I policies relating to virtually every sector of the economy-trade, industry,
hope it will not lose this fantastic ability. I am concerned about India's foreign investment, finance, taxation and public sector. These reforms
future. The greatest problem in India is corruption and not population. have succeeded in large ways in achieving macro economic
The political field has become a real mafia. Political leaders, except a stabilization. The economy is now clearly on the path of global
very few, think about accumulating wealth for themselves and their integration, accelerated growth, improved productivity, innovation and
families. Bribing is a commonplace here and very little is being done to international competitiveness.
check it. When India glories in its "shining" it does not take into account
the vast majority of the villagers who live in absolute misery, Remember
72 % of population of India lives in rural areas; Happy reading
Satya Brahma,
The evils that we see in India today like corruption, public sector Editor-In-Chief, Pharmaleaders Group inefficiency, religious tensions, lack of development, poverty, illiteracy,
poor infrastructure, and shortages are caused by corrupt leaderships
1

P harma-biotech partnerships: creative approaches to doing the Dr Robert Kilpatrick is founder and partner of TVG, which runs the
dealBioPartnering Europe is just one of the many regular BioPartnering conference. He says that because biotechnology is now a global
conferences which bring pharma and biotech together to promote industry, partnering needs to take place in a variety of ways - between large and
themselves and discuss possible deals small companies; Western and non-Western; established and new; and virtual and bricks and mortar. “Openness to new thinking is combined with access to
new markets and novel deal structures, so what is taking place is now termed
Research and development partnerships between big pharma and the biotech 'creative partnering',” he says.
sector are now a vital component in bringing new medicines to the market - so
much so that securing the best molecules for the best price has become a core “TVG launched BioPartnering Europe in 1993 as one of the first life science
competency for big pharma companies. partnering conferences. This year we have held high profile events in three
emerging markets - BioPartnering India in Bangalore, BioPartnering Latin
The relationship between pharma and 'biotech' (i.e. small, start up drug America in Rio de Janeiro and BioPartnering China in Shanghai.
discovery companies) is now mature, and mutually dependent. Declining
productivity from in-house R&D operations means big pharma is becoming “Partnering is just being adopted in these markets and there is a learning curve
more and more reliant on external alliances to produce the medicines of involved. TVG has also learned a lot about partnering around the world because
tomorrow. Conversely, small pharma and biotech companies with limited cash we have worked with over 5,000 companies over a 20 year period,” he
reserves need to find big pharma partners to help them develop and bring their explained.
drug to market. This year's BioPartnering Europe event brought together more than 450
companies from 30 countries, including many biotech companies eager to talk
Around $25 billion was spent by big pharma in licensing deals and other R&D to pharma licensing executives and persuade them that their molecule or
alliances in 2010, a figure which looks set to continue growing over the long technology was worth investing in.
term.
One company was Swiss firm Telormedix, a biopharmaceutical company
The dynamics are clear when pharma and biotech start to negotiate on focused on targeted immunity in the treatment of cancer. Their lead product
licensing; big pharma won't have to pay as much if it buys into a molecule at TMX-101 is moving towards clinical trials in bladder cancer and the company
phase I or earlier, and will face less competition from other big pharma is now looking for partners. Johanna Holldeck, Ph.D., chief executive, who has
companies looking to do a deal. But the chances of the molecule being a failure worked with many big pharma companies, including Roche, Aventis, Schering
are high. and Johnson & Johnson, said: “For biotech companies, it is important to have
core operations in place for licensing. Investors need external validation and if
The alternative is to sign a deal only once a drug has shown proof of concept in big pharma is interested, then the investor will be too. Co-operation with big
phase II or later - but prices are higher, and competition for the deal is greater. pharma also allows access to their expertise and know-how,' she added.
Even then, its success is far from guaranteed.
Innovative molecules, innovative deals
Figures suggest that the trend for pharma is for a greater proportion of deals to
be done in phase III. Statistics compiled by Deloitte in 2009 showed 35% of Partnering deals between biotech and pharma come in all shapes and sizes.
deals were done in late stages, though early stage deals were still more common, Damian Marron, Ph.D., chief executive at Marseille-based Trophos described
accounting for 41 per cent. an interesting deal it struck with Swiss specialist pharma firm Actelion earlier
this year.
Meetings and molecules
Trophos is developing a number of therapies in neurology and cardiology. Its
Partnering conferences are one of the prime means for pharma and biotech to lead compound TRO19622, a novel oxime, is in phase III for amyotrophic
meet and exchange information, TVG's recent BioPartnering Europe being one lateral sclerosis. Actelion's Tracleer, is licensed for the treatment of pulmonary
of them. arterial hypertension, a life-threatening disorder and a $1.3 billion market.
Speaking at the event, Dr Chris Brown, director of International and Primary Trophos needed to refinance and to maintain its clinical programme. Under the
Care, Pfizer, explained how his company goes about finding partners. agreement, Actelion has paid €10 million for an option to acquire Trophos for
€125 million plus two milestones for a further €70 million - US approval of its
“Our collaborations span every area of development. We recognise that some of drug and progress on other programmes. The two companies have set-up a
the most exciting science happens outside the walls of Pfizer.” research collaboration in which Actelion compounds are screened in the
Trophos screening programme.
Dr Brown says Pfizer uses a number of means to identify promising molecules -
by attending partnering conferences, using pipeline databases, venture capital “This deal buys Actelion a new approach to neurology research,” Marron
intelligence and company visits. Promising ideas go through an initial screening pointed out. “It is a good fit for both companies. This deal is not unique, but
(answering the basic question of whether or not it aligns with the company's there are very few like it and they are mainly in the US,” says Marron, citing a
strategy) followed by analysis and due diligence, with assessment from the deal between Novartis and Cephalon as an example. “This is a win-win deal
science, manufacturing, commercial and finance side of Pfizer. Then the which brings us the support of a much bigger organisation, but one that knows
company's business development committee will follow through negotiations what it is like to be a small company.”
with the various deal structure options on the table.
Immutep (Orsay, France) specialises in targeted protein-based
Pfizer is interested in local, regional and global opportunities to partner. “We immunotherapeutics and has recently announced encouraging phase I/II
are looking for late stage compounds with a broad geographical scope. A deal clinical trial (one of seven trials) results for IMP321 combined with paclitaxel
with Pfizer can provide a company with sales and marketing know-how,” in metastatic breast cancer. Dr Frédéric Triebel, scientific and medical
Brown says. director, says that the immunostimulation with first line chemotherapy is a new
approach in oncology. “We are hoping to get a partner because clinical trials
are very expensive and take a long time,” he said.
Biotech Research
2

Biotech Research
interest. But scientific meetings were held between the two companies and
Another company with an innovative product on offer is Genticel (formerly BT when ElexoPharm published a milestone paper in the Journal of Medicinal
Pharma, Labège-Innopole, France). Their cervical cancer vaccine, ProCervix, Chemistry, the deal was completed in April 2010. This deal covers development
can be offered to women already infected with HPV and has recently been and commercialisation of drug candidates targeting aldosterone synthase, a
approved for phase I clinical trials. Dr Benedikt Timmerman, Genticel's chief novel target, in cardiovascular disease.
executive explained: “We want to cure the infection before cancer sets in. Our
product compliments the prophylactic vaccines currently on the market.” Dr Jeroen Tonnaer, the Merck scout in Benelux, Israel and South Africa said
Genticel hopes that their 'first in class' platform will attract a pharma partner. they always look to see how opportunities in the outside world might fit with the
“We have the capability to bring this therapeutic vaccine to market on a global Merck development pipeline. “We are looking for drug candidates in unmet
and regional basis. It is going to be a market of similar value and size as medical need, for novel validated targets which are first in class or best in class,
Gardasil so we need a big partner. The type of deal we are interested in would and solid IP on the target.”
involve licensing with co-development or purchasing the whole HPV franchise.
We are very open to different types of deal.” They are also interested in new synthetic routes and polymorphs of drug
compounds. A biomarker strategy is a plus because it offers the possibility of
Each major pharma company applies their own unique approach to partnering. companion diagnostics. The company is also interested in any technology that
Dr Axel Maibuecher, head of Search and Evaluation for Integrated Hospital helps do things faster, better and cheaper. “More significantly, any technology
Care at Novartis, says his company has a 'three-dimensional' pathway involving that will help us identify or validate novel targets is very welcome,” Tonnaer
stage of development, deal stage, and therapeutic area which “ensures that an added.
opportunity gets the right expertise”.
Another interest area is formulation and delivery technologies, as well as
Novartis has several different franchises and business units, including improved manufacturing approaches and new therapeutics modalities like
cardiovascular and metabolism, neurology and ophthalmology, respiratory and RNAi.
oncology. Novartis is therefore looking for opportunities in type II diabetes,
obesity, dyslipidemia and antihypertensives. “Emerging markets are an important part of our strategy,” added Tonnaer,
listing Turkey, Brazil, India, Russia, China and Korea as examples. They are
Neurodegeneration is another strategic focus and Novartis also has an also interested in Asia Pacific, Latin America, Eastern Europe, the Middle
'opportunistic eye open' in old age psychiatry and mood and anxiety drugs with a East, and Africa.
new mode of action. In ophthalmology, they are interested in wet AMD, from the
strategic perspective, and in dry eye from the opportunistic side. Novartis has a Kilpatrick concludes by saying there is a definite skillset required in deal
long track record in transplantation drugs and is interested in biomarkers in making, whichever side of the fence you are on.
this area. “We are very flexible in the type of deal we will do,” said Maibuecher.
So these will include mergers and acquisitions, research collaborations and “It requires persistence, patience, clarity, communication, access to the right
licensing. people - and a little bit of luck.”
MERCK SHARP & DOHME SIGNING THE DEAL
Meanwhile, Merck relies heavily on the activities of its scientific scouts in The importance of the legal agreement between firms means that lawyers play
partnering, said Dr Barbara Yanni, VP and chief licensing officer. a vital role in the process, usually representing biotech firms.
In 2009, the company signed 51 licensing and partnership deals. “Merck led John Wilkinson, partner at London law firm Reed Smith says setting up a
the field in biotech partnering between 2005 and 2009,” she said. partnership is a painstaking process which typically takes six to nine months.
First, the company with the asset will decide on a deal structure, then start
“We expect to do a lot of deal making in the future. The scouts operate looking for a partner, making partnering events like BPE extremely important.
worldwide, each taking responsibility for their own area. Also presenting at the When a certain level of interest is generated, the details of the deal will be
conference was Dr Margaret Beer, senior director for external scientific affairs, crystallised in order to define the Net Present Value of the asset.
worldwide licensing at Merck Sharp & Dohme. She said: “This is simply the
best job in the world.” There are 17 scouts in Merck's worldwide network, all of The next stage is to generate a Term Sheet, a non-binding agreement which sets
them senior scientists. “Scouting and licensing and the science are so important out the draft terms of the deal. This is where firms like Reed Smith often get
that we will take scientists from the bench to do it,” Beer added. involved, acting for biotech companies and typically negotiating with a pharma
3
company's in-house legal department.
Merck is interested in all stages of the drug development process. The scouts
build close relationships with the local science community including companies, “We help our clients draft a detailed agreement with specific definitions
VCs and academics, and they look in all therapeutic areas. “The most important tailored for agreement,” said Wilkinson, adding that it is important to be
part of my job is relationship building.” aware of the very specialised language of life science at this stage.
Beer adds: “We are as much dependent on our partners as they are on us,
however small the company. I like to think of myself as the friendly face of
Merck in the region.”
What is Merck looking for? The company's areas of interest are published twice
a year, and they are interested mainly in phase III and beyond in all therapeutic
areas. Dr Manfred Horst is the Merck scout for France and Germany. He gave
the example the development of their deal with ElexoPharm, which is a spin-off
from Saarland University in southern Germany. ElexoPharm's synthase
inhibitors were on Merck's list but were originally too early stage to be of real

Generic Drug
are likely to benefit from the scheme. The real ultimate beneficiary, however, Hin India will take time to sort out, but providing free drugs can be
India is also in a position to supply cheap and quality generic drugs to the
ealth economist and advisor to the High-Level Expert Group on
world. Most Indian generic drugs are extremely happy with this decision and
Universal Health Care, S Selvaraj says that tackling lack of doctors
would be patients.Several industrialised countries are moving towards generic
done immediately: What will be the most important component of the universal
drugs. These are substituting branded medicines across the world. The US is no
health care (UHC) package that the 12th Plan is likely to unfold?. Of all the
exception. Recently, Spain had announced a substantial cost savings plan from
components of UHC, strengthening public health system in the country is the
generic substitution.
most significant. The pacing and phasing of reforms are critical and, therefore,
According to recent estimates, Spain is expected to save about $1 billion while
free distribution of drugs is likely to be taken up immediately. This is expected to
the US had saved about $1 trillion in the last 10 years from generic
provide significant financial risk protection to households. The High-Level
substitution. Thailand and China, which are approaching 100 per cent
Expert Group (HLEG) on UHC has asked for distribution of free drugs as the
universal coverage, are moving substantially towards generics.Free drugs is
way forward. But, why did free drug distribution decline from 18 per cent in the
only a part of the grand package recommended by HLEG. Besides, drugs would
1980s to just four per cent in the first place?
put pressure on doctors to be present there. Getting doctors will take time,
while this can be done immediately. So, this is a beginning. Bihar spends Rs 93
Globally, only seven countries are behind India in terms of public health
per capita on health with pathetic results, while Kerala spends Rs 287 — giving
spending. Both the Central and the state governments had to cut down public
it the best health indicator in the country. What is the portion they spend on
expenditure 1990 onwards. The under-resourced public health facilities were
doctors and drugs?
forced to prescribe medicines, which saw patients buying drugs from the open
market in large scale. Gradually, this has led to a situation where a household's
On an average, salaries and other compensation account for 40 per cent of the
70 per cent of health care expenditure is on buying medicines. The health
government's public health spending, while medicines account for 10 per cent.
ministry, as I believe, is putting in place a mechanism that would tie in financial
However, the state governments spending on medicine varies considerably from
allocation to a host of reforms, expected to improve governance and
as high as 13-14 per cent in Tamil Nadu and Kerala to five per cent or less in
accountability in the medicine supply system in the country. The proposed
Punjab, Uttar Pradesh and Bihar. The Central government at present spends
system is on the lines of Tamil Nadu Medical Service Corporation, the time-
10-12 per cent of its overall expenditure on drugs. With additional funds for
tested and successful model based on the principles of 'centralised procurement
medicine procurement, the Centre may end up spending 14-15 per cent, but a
and decentralised distribution'. Since the state governments do not have the
substantial share would go to the statesWhile monopsony and economies of
fiscal width currently to implement the same, the Central government is
scale will help government to procure quality drugs at a cheaper rate, the states
expected to contribute 75 per cent of the additional funds.
are expected to move towards an accountable system. One of the ways to make
the system transparent is enactment of Transparency in Tender Act, as in Tamil
According to the current estimates, the additional funds are expected to be Rs
Nadu.
4,000-5,000 crore (Rs 40-50 billion) a year. This proposal already has the
backing of the Prime Minister's Office and the Planning Commission.The
How will the government finance the programme to raise health spending from
additional funding likely to be allocated by the Centre for the scheme will help
1.2 per cent of the GDP to 2.5 per cent in the next five years, as envisaged by
the states to shore up their fiscal position to procure medicines and distribute
HLEG?. A reallocation in the Budget is called for.There are two ways by which
these freely to patients. Are there enough generic drug companies to fulfil the
drugs can be delivered. The free medicine scheme is one such initiative. By
demand of the government health sector? Which are the existing players? In
strengthening the procurement and distribution system, and with additional
case of these companies falling short, is there a way to generate more supplies?
funding from the Central/state governments, free drugs can be delivered partly.
Well, India has a large number of generic drug companies, close to 10,000. The additional funds, as envisaged in HLEG's recommendation, is expected to
Nearly 250 of them are large and medium industries, while the rest are small- be Rs 12,000-15,000 crore (Rs 120-150 billion) annually. In addition, another
Rs 10,000 crore (Rs 100 billion) is required every year, in order to deliver
scale players. We not only have an adequate number of generic companies; publicly procured drugs but delivered through private chemists. In total, the
4
Can India sustain the 'free for all' generic drugs plan?
The pros and cons of free generic drugs

country will need Rs 25,000-30,000 crore (Rs 250-300 billion) a year to follows on from state-level initiatives in Rajasthan and Andhra Pradesh and is
deliver drugs to people.Currently, the public health system in India spends Rs modelled on Tamil Nadu's successful free drugs programme, which has been in
6,000 crore (Rs 60 billion) annually, of which the states together account for operation since 1995.
nearly 2/3rd, while the rest is contributed by the Central government. On the
other hand, the private consumption of drugs is Rs 60,000 crore (Rs 600 Tamil Nadu set up an autonomous corporation for the bulk procurement of
billion) a year. News of the government's proposal that free generic medicines generic drugs directly from manufacturers through a transparent bidding
be made available through the public health system can be read in two ways. On process, for allocation to primary health centres and hospitals -- through a
the one hand, it is a much-needed step forward – possibly a game-changing one demand-driven pass-book system rather than the normal supply-based
– in improving affordability and accessibility in public health. On the other distribution procedures.Though corrupt practices have not been altogether
hand, its efficacy will depend on whether simultaneous measures are taken to eliminated by this system, they have reportedly been curbed to a large extent.In
improve healthcare service delivery, which is in a shambles in most Indian expanding the programme nationwide, mechanisms to minimise leakages or
states. The Planning Commission's working group on drugs and food for the recycling of publicly procured medicines must, of course, be adopted. However,
12th Five-Year Plan estimated that the country's public health sector caters to a vital prerequisite for the success of the free medicines programme is the
only 22 per cent of the population.Out-of-pocket expenses on health can have strengthening of the existing
healthcare system which has, over the years,
catastrophic effects on households. On an average, 78 per cent of health
tended to expand without consolidation. Most of the country's vast network of
expenditure is paid by patients themselves, of which 72 per cent goes on buying
640 district hospitals, 23,000 primary health centres and 5,000 community
drugs. Unsurprisingly, therefore, about 30 per cent of India's rural population
health centres is understaffed and ill-equipped.
and 20 per cent of its urban population have to endure common ailments
without, for financial reasons, any treatment.
And, of course, there's the question of funding: where will the Rs 27,000 crore
(Rs 270 billion) to be spent on medicines come from? Is this the best time for a
Worse still, close to half of all hospitalisation cases in rural areas are financed
cash-strapped government to expand entitlements?. Who is a poor Indian? One
through loans or the sale of assets.As a result, medical treatment has emerged
who earns below Rs 35 a day? Or one whose salary is in four figures? While the
as the second most common cause of rural indebtedness. Equally disquietingly,
debate rages, the Bombay Parsi Punchayet, the organisation that governs the
some 39 million people are pushed into poverty every year because of illness.
affairs of the Zoroastrian community in Bombay, has said that any Parsi who
The new scheme, therefore, does seem capable – in theory– of addressing the
earns less than Rs 90,000 a month (or Rs 10.8 lakh a year) is poor and
dysfunctional economics of Indian healthcare. The Union health ministry
therefore eligible for its help in finding a house. This "poverty line", drawn way
expects this programme to reach over 50 per cent of India's population by the
above the national per capita income of Rs 68,491 (in 2011-12), was bound to
end of the 12th Plan.Should this happen, it would be a notable achievement.
raise eyebrows. The Punchayet perhaps felt that this was drawing unnecessary
Indeed, in spite of the recent growth of India's private sector health network,
attention to the community's prosperity and hence quickly denied it in its
public spending on health is insufficient to meet requirements.
monthly magazine, The BPP Review.The definition of a poor Parsi, according
to Dinshaw Mehta, the Punchayet's chairman, is anybody whose family income
The Centre and states together spend merely 1.1 per cent of gross domestic
is below Rs 10,000 a month. The poverty line of Rs 90,000 a month was drawn
product (GDP) on public health; some indices rank India eighth last in the world
only for the allotment of 46 flats owned by the Punchayet in Andheri.
on public health spending. The Prime Minister's Office, unsurprisingly, directed
the Planning Commission in February to increase healthcare provision to 2.5
These flats, each of which would cost at least Rs 70 lakh in the market, are
per cent of GDP in the 12th Plan.Like many other such ideas, the new scheme
being given to Parsis for Rs 20 lakh. A loan of this amount, the Punchayet
Generic Drug
5

Generics Medicines
Aamir Raises Revolt Against Branded Formulations, Pushes for Generics Medicines!
Seema, who was operated on “without
permission” appears to have been
presented in haste and without
checking the facts. For example,
according to a rejoinder by the Indian
Medical Association, in this case,
“informed consent” was taken and
was examined by an independent
agency, the Karnataka Medical
Council, which reportedly found no
negligence on the part of the doctors.
These facts were apparently not
divulged by the husband. If the
counterclaims are accurate, there is a
major lapse on the part of the research
team of the show, and labelling the
doctors responsible for Seema's care
“ m a u t k e s a u d a g a r ” a n d
“dhokebaaz” is uncalled for and
probably defamatory.
It is true that issues such as the
mushrooming of private medical
colleges and paucity of government-funded
medical colleges and in
particular, major gaps in primary
healthcare in remote areas, need
strong regulatory calculated, would result in monthly installments of at least Rs 25,000. To pay measures and
this money, the family income ought to be Rs 90,000 a month. "One has to view consistent follow-up actions. But there are many more government medical
the 'poor' in the context of owning a Rs 20-lakh flat, and not 'poor' in isolation," colleges than Khan mentioned on his show. It was stated that since 2001, the
says Mehta. government has opened 31 medical colleges and 106 private institutes;
however, a total of 181 private and 152 government medical colleges exist in
India. To take up these issues in a progressive manner, multilevel action,
political will, administrative firmness, regulatory action on corruption,
grassroots efforts and crusaders in the middle (not those appearing for one
capitation fees in private medical colleges. S
When a prominent person makes statements in the media, there are usually two Khan's article initiates debate on the issue of generic drugs admirably, but does
results: people take those statements to be gospel truths (even if the subject not finish it smoothly. Treatment by generic drugs is an excellent way of
matter is outside the area of expertise of the person making them), and it starts decreasing the cost of medical therapy, provided these generic drugs,
a debate. sometimes made by firms with dubious records, have the same bioavailability
atyamev Jayate' has dangerously over-simplified the generic versus show or writing one article, but consistently devoted to the cause) are required.
branded drugs debate These issues need more thoughtful discussion, rather than emphasising
and quality as drugs made by major pharmaceutical companies. Glimepiride is
Any complex issue with innumerable variables needs careful scrutiny, not not a frontline drug for diabetes, domperidone is not a drug for diarrhoea and
judgements passed on the basis of quickly assembled pieces of information. cetirizine is often not needed for a self-limiting common cold, all of which were
Consider an episode of Aamir Khan's show Satyamev Jayate, as well as a stated as examples of expensive drugs in the article. These mistakes
newspaper article written by him that discussed medical malpractice and the notwithstanding, if quality-controlled generic drugs are available, doctors
issue of generic versus branded drugs. would welcome it. However, if I had a heart attack, and have the choice of being
given the generic streptokinase — another example cited in the article — or the
This is not a claim based on hard evidence, but based on 30 years of experience same drug made by a pharma company with strict quality controls, I would
at AIIMS and then five years in a corporate setup, I can assert that doctors do choose the latter.
not want to harm patients. If patients come in harm's way due to an operation or
other medical intervention, it is attributable to chance. On the show, the case of Corruption in medical practice is a worthy subject for discussion, and the show
was able to initiate this successfully. Discussions of corrupt practices in the
6
IS AAMIR KHAN A NEW MESSIAH OF DEPRIVED INDIA?
Can India Operate on a Chttorgarh Model?

Generics Medicines
medical profession are often avoided within medical circles, signifying a refusal temperature, pressure and humidity at which it is packed or the foil used for
to deal with these important issues head on. The scams, the nexus with Big that or even the weight of the molecule contributes to the efficacy of the drug.”
Pharma and other incorrect practices do, indeed, exist. Nobody should pardon
such unsavoury practices, but many of them emerge from weak supervision, Dr Anoop Kohli, consultant neurologist at Indraprastha Apollo Hospital, says
little regulation, lack of cohesion, an absence of hard administrative action and in reality most common brands are in effect generic because the molecule is not
a lack of firm political will. These factors must be addressed to contain patented by the company selling it. “The only drug that was researched in India
corruption in medical services. was LSD and about 50% of the Indian drug market is of generics — meaning
these are molecules whose patent period has expired and companies who are
I agree that there is little point in achieving high GDP growth if, as a society, we not originators of the drug are selling it. Beyond that it is a issue of quality
remain unhealthy. But health is determined by several factors: genes, individual control because a brand always carries a certain authenticity which doctors
habits, environment, regulations and medical care. Thus, it is not the sole would not like to compromise on.”
responsibility of the government or doctors, both of which Khan's show and
article targeted, but also society at large. Given that many people will follow Doctors, however, agree that if generic drugs is indeed taken up at a policy level
celebrities “blindly” on all issues, how about doing a couple of shows on regular — provided a system of certification for unbranded medicines is evolved — it
exercise, diet and healthy habits, and health education? Such shows, not could be the way forward but the initiative in that case would have to come from
highlighting the negative but intending to build on the positive, would help all of the government rather than individual doctors. States like Rajasthan and Tamil
us to become healthier. Nadu with their respective medical supplies corporations have set a trend.
The writer is executive director of the Fortis-CDOC Centre of Excellence for Using generics is a philosophy and principle that is pro-people and anti-Big
Diabetes, Metabolic Diseases and Endocrinology, New Delhi Pharma. It makes medicines affordable and accessible to tens of millions of
people in India, who otherwise will have to buy the same drug from the original
Aamir Khan's generic prescription shocks medical experts innovator company at a price several times higher. Without them, most of us
will simply perish for want of medicines and the country will be gripped by
It was the actor's suggestion of genericdrugs as a key to affordable healthcare waves of epidemics that will kill people by the thousands. The best recent
for India's poor — as advocated in his weekly show Satyamev Jayate on May 27 example of the miracle that generics could bring about, in driving down the
and subsequently in his column in some newspapers — that got him the call prices and averting mass-scale deaths, was the way they addressed the HIV
from the panel. epidemic.
Experts, however, have said his idea of prescribing generic drugs is “overly When Big Pharma invented anti-retroviral drugs, which almost made the
simplistic” and “potentially dangerous”. illness a chronic manageable condition, they were priced at thousands of
dollars for a year's dose. Even in the beginning of 2000, they were only the
Doctors quote WHO figures of 20-45 per cent spurious drugs in India to counter preserve of the rich in the West, and the rich in countries such as India. Health
Aamir's contention that they are taking patients for a ride. In a follow-up economists from World Bank and national public health establishments
column to his television show, the actor had urged doctors to mandatorily add (including India), mostly borrowing their argument from multi national
generic names in the prescription and let patients choose the brand so as not pharmaceutical companies, were certain that it was impossible to make the
become victims of doctors' “vested interests”. anti-retrovirals accessible to people until Dr Jim Yong Kim, the present World
Bank President and then the head of the HIV unit in WHO, audaciously
For one, as some doctors point out, the recipe could make patients susceptible to declared that he would put three million people on treatment by 2005.
the chemist's business interests as opposed to the doctor's who at least has the
training to balance his “business interests” with what is called in management He betted big time on generics and succeeded. Now, generics have become the
parlance as “information bias”. And it is a proposition that is defunct when it mainstay of AIDS-treatment all over the developing world. People with AIDS
comes to patented anti-cancer and other drugs. in poor countries get their drugs either free or buy at prices less than that of
diabetes. The story is similar for multi drug resistant TB (MDR TB) as well.
“The World Health Organisation says 40% of drugs in India are fake. In case of Even when WHO had more or less given up on MDR TB, given the steep cost of
genericmedicines there is little guarantee of their efficacy or even safety. What drugs, the Boston based Partners In Health (PIH), took to treating people first
if it is a fake? There is no way to determine that. A fake medicine will not allay using the expensive branded drugs, followed by pursuing the generic route.
symptoms, but that is the lesser evil. What if it creates a side-effect for which
the patient needs 10 more medicines. Does that really make it a cost effective Interestingly, the WHO apparently was not even aware that some of the drugs
treatment option?”asks Dr Anoop Misra, former professor of medicine at the for MDR TB had outlived their patent periods and anybody could have made the
All India Institute of Medical Sciences and chairman Fortis Centre of generic versions. But somebody had to compel them and there had to be a
Excellence for Diabetes, Metabolic Diseases and Endocrinology. market for sufficient supplies. PIH took up that role. The point here is, without
the demand and compulsion and a championing voice, we won't get the cheap
Dr D R Rai, secretary general of the Indian Medical Association, says the issue copies of the expensive originals to stay alive. We cannot expect our politicians
of authenticity of the drugs is one among a host of concerns. “There is no to do that. Aamir, by repeating the call for using generics, is contributing to this
effective mechanism for regulation of drug pricing. A chemist will often give campaign. There should be a thousand more voices for such unfashionable
you a drug at half the marked price. If the government cannot even ensure that causes.
registered drug companies charge just price, how will it regulate either the
pricing or the quality of generic drugs which is a far less structured industry? Much before Aamir, the Tamil Nadu Medical Services Corporation (TNMSC),
There is need for a price regulator and DCGI needs to be more proactive in had made a highly successful working model of a state-wide drug procurement
quality control.” and distribution system in the 1990s based on generic drugs. Through several
iterations, the TNMSC has perfected a process to weed out poor quality and
Speaking on conditions of anonymity, a senior doctor at a government hospital ensure reliable supply. Its bulk procurement offered to buy sufficient quantities
said: “Every day I have rickshaw pullers and MCD sweepers coming in to say that made business sense to suppliers. This is in fact the same technique that
doctor saab write the best medicine for my child I will buy it from outside. They Clinton Foundation and other international NGOs would use in future – bulk or
do not know but we know that a medicine is just not a chemical...the pooled procurement.
7

offices, etc.) to see how easy it was for disabled people to move around. Sadly at
Generics Medicines
The TNMSC is now replicated in many other states such as Karnataka, Andhra most places it was almost impossible.
Pradesh, Rajasthan and Kerala. On Wednesday, the Kerala chief minister The next guest was Krishnakant Mane who prefers to be called KK. He lost
Oomen Chandy used the same “generic” word in the state assembly when he sight when he was three but never lost his way. He does everything a normal
answered a question on free supply of some medicines. So Aamir is perfectly person does including trekking and is a top-grade software engineer whilst
right in campaigning for generic drugs. But then in India, the same generics doing research work as well. He explained how technology has helped him and
come in different brands and that is where he wanted the people and not the felt people should remember two important things 1) Don't think you're disabled
doctor to choose the brand – his second point. Here, he is as simplistic on a 2) Stop expecting the world is there for you; it'll be cruel and kind to you in
complex issue as team anna is on corruption is. His intent is clear — the doctor equal measure. He said it's wrong to blame the government and society had a
doesn't take a call on the drug because he/she is heavily induced by drug role to play in allaying the problems of the disabled. The show then went on to
companies; but who does the patient go to with the prescription? The highlight how hard it is for people with disabilities to get admissions in regular
pharmacist, who cannot be any better than the doctor. And the pharmaceutical schools. One principal in the audience blamed it on other parents who refused to
companies will simply shift the goal post. Instead, what Aamir could do to take let their 'normal' children mix with children with disabilities. The show then
his generic argument forward is to argue for a prescription method in which the pondered if it indeed was a challenge to admit disabled children in regular
doctor writes both the generic and branded names of the drug. And the patient, schools. Amar Jyoti School in New Delhi showed it wasn't and that only some
who wants to buy the generic version, then goes to a fair price drug shop run by changes need to be made to provide an environment where everyone can be
the government or a cooperative across the state. given an equal education. There is a general consensus among people that
disabled people are being 'punished' for their sins from a past life. Aamir
Fair price drug shops like the PDS? pointed out the very successful polio eradication campaign and lauded the
country's effort in eradicating the disease, pointing out that past sins had
Yes, Kerala is now planning one in every district. Chandigarh has a few. The nothing to do with disabilities.
government drug corporations (eg TNMSC) can set up such shops in district
and Taluk headquarters and extend it to even PHCs. Of course, there were Then the show focussed on various people who've fought their disabilities and
exceptions such as the one in Mohali that got into a nexus with the drug what can be done to improve their lives.
mafia.Some media reports carried stories expressing shock at Aamir's
statement while a Parliamentary panel wanted to hear him out. Here is a line One example was a young girl called Nisha who suffered from a rare genetic
that Aamir might do well in telling the panel – this one straight from the WHO: disorder called Lamellar ichthyosis that affects 1 in 6 lakh people. In this
“competition between drug companies and generic producers has been more condition the skin fails to grow alongwith the body which results in a host of
effective than negotiations with drug companies in reducing the cost of drugs.” problems. Ketan Kothari of Sight Savers said people needed to change their
Let the drug companies and their crony doctors be shocked, but Aamir should stereotypical attitude about people with disabilities. He said the term
pursue his statement with action. For once, he is not treading on unknown 'differently abled' was insulting and there was nothing wrong with calling
terrains. Dr Kim, Bill Clinton, and many Indian states had successfully someone disabled.
traversed this path. Less popular issues such as this need ambassadors like
Aamir. After all, 75 percent of our health expenses are from our own pocket and Javed Abidi, the director of the National Centre for Promotion of Employment
there is considerable push for universal access to health in the 12th plan. for Disabled People (NCPEDP) in India, and the founder of the Disability
Without generics, we wont reach anywhere. Rights Group said there were 6 crore disabled people in the country though the
government refuses to acknowledge that the numbers are that high. Till 2001,
Aamir Khan is an ignoramus. none of the censuses even accounted for disabled people and though the 2001
A generic drug is a drug out of patent. All drugs in India are generics!
They are 'branded' generics because they carry the brands of the companies that
manufacture the generic drug.The Brand is necessary, because this helps
differentiate the genuine drug companies (many with US FDA approved plants)
from fly by night operations that make drugs in garages and rented Galas. Yet,
fake falsely labeled branded generics are the bane of the industry and the
patients who suffer consequently from drugs with low bioavailability and
effectiveness. India has a fragmented drug market with top 3 companies having
3% - 7% of the market. This results in fierce competition that result in the
lowest prices in the world. The Drug Price Control Order already controls the
prices of essential drugs and is now due to expand and cover ~67% of the drugs
available. The real problem is not price but ACCESS. Today 60% of Indians
have no access to pharmacies and prescription drugs
Satyamev Jayate's sixth episode highlighted the trials and tribulations of people
who are disabled (the politically correct 'differently-abled' is considered an
insult by many). It highlighted the various problems people with disabilities face
and how easily it can be overcome only if society were a little more considerate
and aware of their needs. The first guest was a Sai Prasad Vishwanathan who
recalled how he was never treated differently by his parents and encouraged to
attend normal schools though this was made difficult by the authorities. He said
that the biggest problem people with disabilities face are the lack of adequate
infrastructure to move around. He explained how different things were in the
USA where his university had provided adequate infrastructure for him to move
around with any problems. To check the facilities available for the disabled the
Satyamev Jayate team checked various public locations (bus stops, government
8

Generics Medicines
did take note none of the measures had been implemented. He added that it was
fundamental right that was being snatched away and it was a paramount We've covered the rights. But what's equally important is patients understand
importance in a democracy that everyone should be treated equally. The policies their responsibilities as well:
and tax structure pertaining to disabilities needed to reworked as he pointed out
it used to cheaper to bring back gold from a foreign country rather than a The patient should undergo the treatment as prescribed by the doctor
wheelchair which had a customs duty of around 30-40%. He said the only way faithfully and follow his/her instructions diligently.
to ensure disabled children were included in regular schools was for the If the doctor has prescribed certain preventive measures in case of
University Grants Commision (UGC) to give a notice to all schools and infections, the patient should follow the same.
universities to include disabled children in their courses or become The patients need to be punctual for the treatments and follow-ups.
unrecognized by the UGC. Patients should maintain all the medical records and prescriptions.
If the patient wants to take a second opinion, consult with your doctor
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He also pointed out the bad employment scenario for disabled people with only about the same.
0.4% of them employed in private companies and 0.5% employed by public Ÿ
Patients should pay for their treatment as applicable to the doctors and
sector ones. It was simply foolish he added to keep disabled people grounded hospitals promptly
and not let them contribute to the country's economy.
Excerpts from the Interview :
Dr Rajendra Joher of the Family of Disabled also highlighted the work he was
doing to empower the disabled. Incidentally Dr Joher was deemed bed-ridden Satyamev Jayate's fourth episode made the term generic drugs popular.
for life but he got past his own disability and is now helping others deal with Generic drugs have been around for ages. In fact India's the global leader in the
theirs. Aamir Khan went on to talk to Captain Kamaljeet Brar whose company generic market with Indian drugs popular in Africa and other emerging
Designmate employed over 70% disabled people. It's an e-learning company markets. Some Indian pharmaceuticals have even made headway in the USA
that employed over 270 disabled employees and was doing very well market.
highlighting the fact that disabled people can make a major contribution to
soceity. The last guest on the show was Joginder Singh Saluja, a disabled So what are generic drugs?
bodybuilder and weight lifting champ who started a gym for the disabled
because regular gyms denied him entry. The show wrapped up with Aamir They are drugs which have the same chemical composition as branded drugs
asking the audience to write in and support the motion that will force all schools are and sold under their chemical name. For example Paracetamol , a
and colleges to become inclusive failing which their UGC status would be painkiller, is the generic name for branded drugs like Crocin and Calpol. The
revoked.In the end, Ability Unlimited a group of disabled performers moved drug market situation is a little different in India than the USA or other
everyone with their astounding moves. All in all it was another great episode of developed nations. In the USA, when a new drug is launched only the company
Satyamev Jayate focussing on an issue we seldom dwell upon. that holds the FDA patent are legally allowed to sell the drug , thus giving them
market monopoly. In India however there were no patent laws till 2005 which
The fourth episode of Satyamev Jayate brought to light several cases of medical meant that anyone could replicate any drug in India without legal
malpractice. Most patients in India treat their doctors like Gods and have an ramifications. This led to the trend of branded generic drugs which has 99.5%
unquestioning trust in them. However, in recent times, there have been cases of of the country's generic drug share
medical negligence and/or malpractice due to which the patients have suffered
physically, mentally, financially and emotionally. In 1995, the Supreme Court Where are they available?
brought the medical profession under the Consumer protection act and medical
treatments were labelled 'services'. As per the Consumer Guidance Society of Generic drugs are sold everywhere including your local chemist. To buy them
India, the patient's rights as a consumer are the following: one simply has to ask for generic version of a branded drug though they don't
have them for all medicines. The department of pharmaceuticals of the
Patients have the right to be told about their illness; to have their medical government is responsible for promoting generic drugs but they haven't done a
records explained. very good job. To promote cheap drugs in 2008, the government had set up a
Patients should be explained about whatever treatment/medicines are scheme called Jan Ausadhi whose purpose was to set up generic drugstores
prescribed to them. They should be made aware of the risks and side around the country. Their initial plan was to set up 3000 stores but four years
effects, if any. They have the right to ask questions and clarify their doubts later only 300 of them exist. Here's a list of all Jan Aushadhi stores in the
about the treatment. country.
Patients have the right to know a doctor's qualifications.
Patients have the right to be handled with consideration and due regard What is the price difference between generic drugs and popular branded drugs?
for their modesty when being physically examined by the doctor.
Patients have the right to maintain confidentiality regarding their illness Note: All prices are taken from the 2010 comparative price list
and can expect the same from the doctors. We can clearly see that in some drugs the price difference is significant.
Patients have the right to a second opinion if they are doubtful about the
medicines or treatment suggested. Note: The list compares prices of generic vs braded drugs from 2010. As we can
Patients have the right to know what a suggested operation/surgery is for see except for the anti-TB drug there's a huge price difference.
and the possible risks involved. If he/she is unconscious or unable to make
the decision due to other reasons, informed consent needs to be taken from Is there a difference in quality between generic drugs and branded ones?
their nearest relatives. This is a question which is hard to answer and polarises the entire medical
Patients have the right to get their medical records/case papers on request fraternity – doctors, chemists, pharmaceutical reps, etc. Some of them say that
from the doctor/hospital. they are as good as branded ones while others feel that they are of poorer
If the patient needs to be moved to another hospital, he/she has the right to quality. Doctors and chemists have the impression that they are less effective.
know the reason for it and also has the right to make their own choice in In fact some doctors avoid prescribing generic drugs as far as possible and even
consultation with the doctor. go to the extent of handing out free samples of branded drugs to patients who
Patients have the right to get details of the bills they have paid for. can't afford branded medicines. Doctors also aren't aware about their
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availability due to lack of advertising and marketing. On the other hand a examples of positive work by doctors like Dr. Devi Shetty and Dr. Shamit
pharma rep we talked to was of the opinion that there is no difference in quality Sharma,” Aamir told IANS.
and a generic drug was as good as a branded one.
He denied the accusation that he insulted the medical profession. ”I have not
Why aren't generic drugs more popular? insulted the medical profession at all. I have the highest regard for the medical
profession. In fact what is insulting to the medical profession is those doctors
There are various reasons for their unpopularity. There is a distinct lack of who are indulging in unethical practices. They have insulted the medical
awareness about them. Before the Satyamev Jayate episode only a handful of profession, not me,” he said. However, he is happy with the positive response
people knew them. Also since they are cheap, people who can afford branded from the medical community as well as youths who aspire to be in the
drugs don't buy them believing them to be of inferior quality. Chemists have to profession.
hand out exactly what's written on the prescription and most doctors except in
government hospitals don't hand out generic drugs. “A lot of doctors have written to me and said, 'Your work is fantastic and we are
thank you for what you have done'. Dr. K.K.Talwar, head of the Medical Council
An insider felt that private doctors would never hand out generic drugs because of India, was on our show and after the show was aired, he wrote to me saying: 'I
there are no kickbacks or incentives involved from pharma companies. thought what you did on the show was very good.' ”He said that 'I am aware that
According to a highly placed source in the MCI, the body has very little say in a small section of doctors is upset with you, but I want you to know that what
the doctor-pharma relationship. Most guidelines are blatantly ignored. The you are doing is very important and I want you to know that MCI and I will do
government or specifically the government's Department of Pharmaceuticals is everything we can in our control and power to set things right'. Now that is such
also to blame for the lack of awareness. The DoP has failed to do a good enough an important and encouraging response. “Young medical students have written
job of promoting generic drugs and the aforementioned failure to implement the to me that this is a profession we are about to enter and we are so inspired by
Jan Ausadhi scheme reinforces that. your show to do the right thing when we enter the profession,” he added.
How to promote generic drugs “I want to thank these doctors and young medical students whose messages and
letters have been most encouraging” he said. Aamir says his conviction in the
Generic drugs are the answer to better healthcare for all. India has one the concept and aim of the show have left him fearless of negative reactions. ”I feel
highest out-of-pocket healthcare expenditure in the world and despite providing what I have set out to do is extremely important and what I support is important
very cheap services (compared to rates of the countries like USA and UK) it's for me and very important for society and our country. I have absolutely no
still inaccessible to many due to poor purchasing power. The only way to hesitation in doing what I feel is right for the country. So in that, if there is a
promote generic drugs is to curb illicit medical practices. Though the MCI small group of people who are getting upset, it is sad, but so be it. In fact, I
guidelines dictate that doctors should prescribe generic medicines as far as would request those people who are getting upset to look inward.
possible, very few private practitioners actually do it. There's a need to
strengthen the Jan Ausadhi scheme and break down the doctor-big pharma “I believe we are trying to make a sincere effort in first understanding issues
nexus. Moreover the MCI needs to provide more practical guidelines rather and then shedding light on them, and we are committed to that attempt,” said
than an archaic set of rules which simply can't be followed in the real world. the 47-year-old trailblazing cinema personality.
Pats and brickbats – Aamir Khan was prepared for it all when he set out to People trust medical practitioners, believing that they are equipped with the
discuss burning issues in his debut TV show “Satyamev Jayate”. Fearless and knowledge and skills to safeguard their health. But when this knowledge is
convinced about the aim of the show, the actor-filmmaker says he is totally misused to exploit this trust, medical care becomes a nightmare. The
unapologetic about raising the issue of malpractices in the medical profession, profession is riddled with unscrupulous doctors and hospitals out to make big
thereby upsetting an umbrella body of 21 medical institutions.“I have bucks at the cost of patients, but there are still medical practitioners who stand
absolutely no intentions of apologising because I have not done anything up for the Hippocratic Oath, and those who want to clean up the profession.
wrong,” Aamir told IANS in an exclusive interview over phone from Mumbai.
After raising concerns over female foeticide, dowry andchild abuse, Aamir took Medical Nightmare
it upon himself to shake up viewers and awaken them to the existence of
irregularities in the country's healthcare system. He brought issues like cut It is generally believed that health is wealth; one can tackle any of life's
practices, unethical medical practices, and commission demands to the fore and problems if one is in good health. But when one is not in good health, whom does
presented live examples of people who could have been cured with simple one go to for help? A doctor, of course. In this episode, in the audience there are
medicines but were advised by doctors to undergo surgeries, robbing them of many young medical students. Asked why they want to become doctors, the
precious money. This 'exposure' has landed Aamir in the bad books of the Indian general response is, to help people. When our future and wellbeing is in the
Medical Association (IMA). But he does not fret! hands of medical professionals, it is pertinent to examine issues related to
medicine and doctors. The episode begins by examining the relationship
“We were aware that since these are issues that are core to all of us and between a doctor and a patient. We see the stories of two people, V S Venkatesh
affecting every Indian, obviously there are some people who are part of the and Arvind Kumar. Venkatesh had a swelling on his foot and when he went to
problem, and they are not going to be happy with us because these are the ones the doctor he was told that if he did not go to hospital he would lose his foot.
who don't want a solution to be there. ”In fact, I would have been surprised if we Venkatesh got admitted and was treated, but an infection developed in his foot
would not have earned brickbats. The people who are getting troubled are very the next day. He was told that a toe needed to be amputated. After that, he was
likely the ones who are part of the problems,” said Aamir, adding that he hasn't told that the doctor who had performed the surgery had left some bone inside.
received any physical threats so far. One after the other, four operations were carried out – and eventually
Venkatesh learnt that none of this had been necessary, and that he could have
He protests against the allegation that he only highlighted the negative aspects been treated with antibiotics and other medication. Venkatesh is seething at the
of the medical profession on his show, to which was invited K.K. Talwar, loss of his toe, the loss of more than Rs 2 lakh towards treatment, and the sheer
chairman, board of governors, Medical Council of India (MCI).”I don't know trauma that he was made to undergo.
whether they have seen the show because a number of times we brought out that
there are many doctors who are doing great work. We gave such strong It was a similar story with Arvind. Troubled by persistent vomiting, Arvind
went to hospital for a checkup and was admitted to the intensive care unit for
Generics Medicines
10

Generics Medicines
three days, to undergo several expensive tests. He was then told that his being given as normal, because the doctor knows that there is nothing really
appendix had ruptured and would have to be removed, otherwise he would die in wrong with the patient. Dr Pichad says that it was a personal tragedy which
three hours. But Arvind did not believe the doctor, and went to another hospital brought him to his senses. He realized that what goes round comes round, and
for a second opinion. There, more tests were carried out and he was told that he felt that he should make amends for his bad practices. He stopped giving
there was nothing wrong with his appendix. He ended up spending Rs 1,40,000 commissions, and reduced his rates. He found that as a result, he lost his doctor
between the two hospitals, for no reason. Now, he says, he is afraid to go to a friends, he stopped getting referrals, and often his reports would be rejected by
doctor. Venkatesh remarks that people practically worship doctors, but in the doctors. He says that after explaining to his patients that nothing had
reality they play quite a different role. When Daya Suryavanshi's father was changed in his lab except the pricing, and after he made it known that he was
feeling uneasy one night some years ago, he went to hospital, where he was refusing to pay commission, word of mouth spread and his business began to
admitted to the ICU for tests. After two days of tests he was told that his pick up. He has also displayed a board at the reception area which says that his
condition was serious, and that he needed a liver transplant otherwise he would lab does not operate on a commission basis. With patients gaining confidence
not survive beyond two or three weeks. Worried, he sought a second opinion in him, his business is now doing well without him having to pay off any doctors.
from a doctor referred by the hospital itself. This doctor echoed the first opinion,
and Daya's father then went to the family doctor. The family doctor diagnosed But the system of commissions and payoffs is rampant, and sickening. Cancer
gastroenteritis and said there was absolutely no need for a liver transplant. surgeon Dr. Amol Pandit of Wales explains via 3G link that when he came back
Daya's family spent some Rs 25,000, not counting the ICU charges, on all this – to India to practice, he learnt from his colleagues that they expected a “cut” of
but if they had agreed to the liver transplant, it would have cost them some Rs 30 to 50 per cent for referring patients to him. In big hospitals, he says, he was
36 lakh. expected to give patients medical opinions that would scare them into agreeing
to surgery at the hospitals, at cost to them and profit to the hospital. Refusing to
For retired army Major Pankaj Rai and his daughter Abha, the cost was much, go along with these schemes, Dr. Pandit returned to the UK, disheartened and
much greater. Maj Rai's wife Seema developed kidney disease, and had to disillusioned with his native land.
undergo regular dialysis. Seema could well have continued for many years with
dialysis but on the urging of the doctors, though she was apprehensive of the Unscrupulous doctors are to be found everywhere, even operating among the
outcome, Seema went in for a kidney transplant when a donor became poorest sections. In Andhra Pradesh, poor women had hysterectomies
available. One day before the surgery Maj Rai was told that his wife would also performed on them under the threat of losing their lives if the operation was not
need a pancreas transplant. He did not agree, but he was asked to speak to a performed. Many of them took loans, or sold their land, to pay for the
cardiologist before making up his mind. The day of the surgery, at about 5am, a operations, and in some cases, after the women realized they could not have
nurse told Abha that her mother was to be taken for a checkup, and asked her to children, their husbands left them to remarry. In reality, as Dr Puneet Bedi
sign a form; before Abha knew it Seema had been wheeled away into the explains, leaving aside the case of cancer, a hysterectomy is rarely required –
operating theatre. By the time Maj Rai arrived at the hospital, he was told that perhaps one patient in every four to six months. He says it is impossible that so
surgery had begun and it could not be stopped, despite his protests that many women in the same area would need a hysterectomy. Who can curb this
permission had not been given for it. The Rais were then told to arrange for rampant abuse of the medical profession? The Medical Council of India is the
replacement blood, and Maj Rai says that eventually they ended up giving regulatory body that is supposed to keep a watch on medical malpractices and
Seema a total of 7 litres of blood – even more than is contained in the human give recognition to medical colleges. In 2001, MCI chief Dr. Ketan Desai was
body! Maj Rai says that neither was a cardiologist consulted before the charged with corruption and Maj Gen (Retd) Som Jhingon was appointed
operation, nor was the transplant surgeon qualified for a pancreas transplant. administrator of the MCI. But the den of corruption, as Maj Gen Jhingon terms
Also, the hospital did not have a license to carry out pancreas transplants. it, was too much of a battle even for the war-hardened army veteran. Stymied at
Seema was on the operating table for 17 hours and was in critical condition for every turn by the corrupt practices kept going by Dr. Desai's regime and
two days after that. Maj Rai says that he met her one evening, and she told him supporters, he resigned, and Dr. Desai was back in the MCI. But only till 2010,
that he and Abha should look after themselves. She passed away that night. when he was nabbed on a bribery charge by the Central Bureau of
Abha says that they were not even informed about this, until she asked one of the Investigation. This time, the MCI was handed over to Dr. K K Talwar to run.
staff how her mother was. That was when she was told she was no more. The Rais
spent Rs 8.25 lakh, and Maj Rai feels that the hospital took a gamble on the Dr. Talwar admits that the malpractices which are now coming to public
pancreas transplant, hoping that if it went well the institution would gain a attention are bad, and that change is required. Granted that all of the
name, and if it did not go well it was no big loss – only the loss of a patient's life. approximately 8 lakh doctors in India swear to abide by the code of medical
Maj Rai says Seema had told the nephrologist that she had complete faith in him ethics, Dr. Talwar says it is difficult to say how many doctors actually abide by it
and while she may even ignore what her husband told her, she trusted and and how many break this code. Aamir Khan points out that as per a Right to
believed the doctor. It is a faith that doctors play upon. Aamir Khan explains Information application, it is learnt that not even one doctor's licence has been
that while doctors may make mistakes just like any other human being, the cancelled since 2008. In contrast, in England, in 2010 73 doctors lost their
episode is focusing not on mistakes but on intentions, on doctors who licences, 68 in 2009, and 42 in 2008. Dr. Talwar says that there are good
deliberately mislead and exploit patients. doctors and bad doctors, and a solution to the malpractice problem needs to be
found. He assures Aamir Khan that action will be taken in the Andhra Pradesh
The percentage game hysterectomies cases, and promises to make a serious effort to clean up the
system. Asked how much capitation fee is charged by private colleges, the
Even when the situation is not as serious as to require hospitalization, in regular medical students in the audience say it is about Rs 60 lakh. This is all black
treatment too, patients are often advised to have blood, urine and other tests money, paid in cash, and there is no record or account of it. Dr. Talwar admits
done. Dr. Anil Pichad explains the business of running a pathology lab. He says that some of these institutions and the hospitals attached to them are not up to
that when he started his pathology lab, he did not get patients for a couple of standard, and says that this is a long-standing issue which needs to be
months, then he realized that he would have to go and meet doctors to let them remedied. He promises that action will be taken in the cases of erring doctors
know about his lab and services. He found that doctors would straightaway ask and institutions.
him for a percentage, of about 40 to 50 per cent, in return for referring patients
to his lab for tests. This naturally resulted in the cost of the tests being raised for Rays Of Hope
the lab to be able to make a profit. Moreover, says Dr. Pichad, doctors often
prescribe more tests than are required. In fact, one such test is called a “basin Just as there are people who are part of the problem, there are people who are
test”, and involves the blood sample being thrown into the basin, with reports part of the solution. Dr. C M Gulhati is one of those who has long been
11

Generics Medicines
concerned about medical ethics. He says that the basic question is, whether we Dr. Sharma says that medicines are overpriced because of the brands they are
give medical services priority or not. He says that while medical care should be sold under. Generic medicines are unbranded and therefore cost less, though
No 1 priority, it has actually been pushed to the very bottom. The reason for this they contain the same basic salt that is used for the treatment. He gives the
is the privatization of medical colleges, where students have to pay enormous example of a medicine for diabetes, which costs Rs 117 for a branded version,
fees to get admission. When they have paid so much, he reasons, they expect to but only Rs 1.95 per 10 tablets for the generic. A cancer drug that costs Rs
get the same kind of returns from the profession. He says it would be a better 1.25 lakh can be had in generic form for Rs 6,500 to Rs 10,200. In fact, India
option to invest that money instead of spending it on a medical education. Dr. exports some Rs 45,000 crore worth of generic drugs every year.
Gulhati says that the solution is to have more government hospitals, because at
the moment the number of government hospitals is not enough to serve the Dr. Sharma says that the movement he has started in Rajasthan for the use of
population, and people have to either wait long hours or come away untreated. generic medicines has attracted a lot of opposition especially from the
Another ill of the profession is the practice of pharmaceutical companies pharmaceutical company mafias, who end up losing their hefty profit margins.
encouraging doctors to prescribe their products, with incentives. Dr. Gulhati But he says the movement has the support of doctors, not all of who are bad.
says that this incentive again is in the form of a commission of 30 per cent paid There are 50 to 60 per cent of doctors who genuinely want to help people, and
to the doctor. Pharmaceutical companies, he says, spend Rs 1,31,000 per often shell out of their pockets, or bring samples of medicines to give the poor.
doctor per year for these commissions. Dr Gulhati says that while taking a bribe He says that when he was away once, his domestic helper's son died because she
is an offence, the pharmaceutical companies do not come under any sort of could not afford the medicine which cost Rs 400, but which was actually
liability. He says that health care is neglected because it affects mainly the poor, available for Rs 1.25. It is criminal that this happens, he says, and even worse is
and he recommends that it should be equally accessible to all. He cites the the fact that it is not difficult to change this.
example of Belgium where a percentage of salary is automatically credited to a
medical insurance company, so that good medical care is available to all. He Aamir Khan says that if any NGO wants to set up a medical store selling generic
says that of India's Gross Domestic Product, only 1.4 per cent is spent on health medicines, the Department of Chemicals and Fertilisers offers a grant of Rs
care, and it will never improve until this figure reaches 6 per cent. In the midst 50,000 for this purpose. The SMS question is: Should every state government
of this bleak scenario, a ray of hope comes from people such as Dr. Devi Shetty. follow the example of Rajasthan and open generic medicine stores throughout
Founder of the Narayan Hridayalay in Bangalore, Dr. Shetty instituted the their state so that all citizens get medicines at the lowest possible price?
Yashaswini scheme for farmers nine years ago where the farmers each pay Rs
10 per month, which the government matches with Rs 30 per year, and this What can be done?
makes the best medical care at Dr. Shetty's hospital available to everyone. Dr.
Shetty says that any type of operation is possible under this scheme. Poor people The SMS question for the episode. And, Aamir salutes doctors who are working
living in isolation are weak, but together they are very strong, says Dr. Shetty. selflessly and tirelessly in the genuine spirit of their profession – helping people
He explains that while the so-called rack rate for a heart operation, for and being healers – and appeals to medical students to hold such doctors as
example, is Rs 1,40,000, his hospital does it for Rs 60,000 for patients under their ideal.
the scheme. He says this is possible due to the turnover, as his hospital carries
out the largest number of heart surgeries in the world – about 35 in a single day. Does Healthcare Need Healing?
Health care is sensitive to economies of scale, says Dr. Shetty, so the fact that his
hospital group performs 12 per cent of the heart surgeries done in India gives
him the advantage of being able to lower costs. He says that this is possible The practice of medicine has long been seen as a noble one. The doctor is looked
anywhere, and in fact a similar scheme was started in Andhra Pradesh about upon as healer, guardian of our well-being, and someone we trust with our lives.
four years after Yashaswini, and another one has been started in Tamil Nadu. If Literally. In India, with privatization and globalization having brought in
the government can be convinced that there are 750 million Indians who are modern medical equipment and techniques, no longer are the choices limited
spending Rs 150 per month just to talk on their cell phones, and if Rs 10 can be when it comes to finding a doctor. Now, the question is which doctor at which
collected from each of them, we can have the most robust health insurance hospital or clinic to choose. In the midst of this bounty, it is heart-breaking that
scheme. more than 16.8 lakh children under five died in 2010 – of diseases such as
pneumonia and diarrhoea, diseases that are easily curable if treated with the
Dr. Shetty says that charging less does not mean that the doctors in his group right medicine. *
are earning less. Everyone is doing very well, he says, and exhorts medical
students and doctors to do what their heart tells them. Those who indulge in But the reality is that health care, and specifically the cost of medicines, itself
malpractices are also always afraid of being caught, he says, and they cannot drains the average pocket so much, that large numbers of people are often
sleep easy as their conscience is not clear. He tells the audience, “Nobody can forced to go without appropriate treatment. Adding to this are factors that do
come in the way of people wanting to do something good for society. You all can not help the medical industry, such as some corrupt practices, patients being
be heroes in real life. This is a fantastic profession.” overcharged, and prescribed treatment and surgery they did not need. Why is
the simple act of giving and receiving medical care so fraught? It begins,
The Cost Of Medicine perhaps, with the very notion of studying medicine. Once considered a rarefied
and glorious stream of study, medicine slowly came to acquire a cachet of
A major part of health care is the pharmaceutical profession. And the cost of prestige. Parents pressurized children into it, eager to boast that their child was
branded medicines can be astronomical, as can the difference between these a medical student. Students, egged on by peer pressure, applied for medical
and generic medicines. Showing by example that one does not need to pay overly college and, bizarrely, opted for the “alternate” stream of Engineering if they
high prices for medicine is Dr Samit Sharma, former collector and now did not get into medical college.
Managing Director, Rajasthan Medical Services Corporation. He says that the
daily tragedy of India is that medicines are sold at up to 50 per cent more than With globalization came a wave of knowledge, awareness of alternative
they should actually cost. When there are more than 40 crore people in India streams of work and jobs that, under socialist India, had been looked upon as
who cannot even make ends meet, how will they be able to afford such “loser” choices. But medicine was still the shiny option. Nevertheless, it is still
medicines, he asks. According to the World Health Organization, he says, 65 not a cheap option. Besides the actual study and other fees, the practice of
per cent of the population of India lacks access to essential medicines – 65 years capitation fees in private colleges, which had become popular in the late 1970s
after Independence. and 1980s, has taken firm hold in the world of medical education. Over and
12

Generics Medicines
above other fees, a student may be expected to pay anything from Rs 50 lakh private entity should discuss the issue, evolve a consensus, take doctors and
upwards as “donation” towards the college, in cash. This is a sizeable amount staff into confidence and adopt a resolution to provide low-cost drugs to the
which many doctors are under pressure to recover as quickly as possible when citizens. Take from the doctors the list of drugs which are commonly prescribed
they qualify and begin practicing. by their generic/salt name (start with 100-200 drugs which are not available in
hospital supply). Let doctors also decide the name of 15-20 companies which
The plethora of private medical insurance schemes available help the educated they consider as “good”. Invite open tender by generic name or take drug lists
and privileged to cover medical costs – but for the vast majority of India's poor of reputed drug companies (which doctors have indicated) from the authorised
and lower-lower middle class, medical insurance is unviable. The only ray of local stockists (the wholesalers) of these companies. Apart from the offer price
hope for the less privileged comes from micro-insurance schemes implemented the stockist lists usually also shows MRP which may be 5 to 10 times the offer
by state governments – a facility available only in a handful of states. For those price. To avoid misbranded or spurious drugs always get these from a stockist
with access to medical insurance, access to health care became easier to pay for, authorised by the company. Also insist for the authorisation certificate, a valid
but this did not guarantee the quality of that health care. Moreover, it still left a bill/cash memo and certificate of analysis (test report) for every batch of each
gap in the numbers. At last count, India had more than 6 lakh allopathic drug. This will ensure quality standards. Compare the prices of different
medical practitioners – but this means only one doctor for every 2000 people.* companies and prepare a comparative statement. Choose the L1 (best buy) and
Even 24 hours in a day would not suffice to treat this number. This also means purchase these generic drugs. A fair price generic drug store can be opened in
that doctors are still “in demand”. The Medical Council of India itself says, in any suitable vacant room near/in the hospital. A registered pharmacist is
its chairman's note, “The large gaps in health care accessibility in rural parts of required to run the store. The licence for the shop is to be obtained from the
the country, the need for enhanced clinical competence and limited office of the local drug control authority, for a licence fee of about Rs 3,000
opportunities for post-graduate training are our major concerns.”* (one time for 5 years). The generic drugs received from the authorised suppliers
can be sold at 10-20% profit margin which is charged at the purchase price,
Even when doctors are available, and are affordable, the basic problem is that which will help to meet day-to-day expenses and the remuneration of the
the medicines they prescribe are not always within the budget of the average pharmacist, and no external financial help is required. A computerised list of
person. On the whole, the cost of medicines itself makes up a major part of our the available generic drugs may be displayed prominently outside the shop.
health care expenditure, and the tragic reality is that this does not have to be so. Preferably the list should show the rate at which the drug is actually sold
The medicines available in the market are sold at prices which can be anywhere (CP+10%). You may also compare the selling price with the MRP printed on
from 10 to a thousand times more than the actual cost of the medicine. A 2010 the drug, which will educate the patients about drug prices.
Parliamentary standing committee report on generic medicines, for example
noted that a seven-day pneumonia treatment costs Rs 1,136 when actually the Similarly, surgical items like IV sets, blood transfusion sets, needles, canulas,
medicine, when purchased at a cooperative generic medicine store, cost only Rs suture items etc can be sold. Orthopaedic implants, eye lenses, cardiac stents
139.51.* etc can be sold at about one-fourth of the prevalent market prices. The mere
availability of low-cost drugs will not help, until the doctors can be persuaded
Some state governments – including Rajasthan, Tamil Nadu and Bihar – have to prescribe either the generic (salt) name of the drugs or at least prescribe
started cooperative and other stores selling medicines in their generic, non- those brands which are of low cost and are available at the store. Then the
branded form, at a fraction of the branded cost.* If this movement can be taken patient must be properly guided and counselled to purchase drugs from the low-across
the country, to every state and every town and village, it will give every cost generic drug store. In Rajasthan about 72 fair price generic medicine
Indian access to affordable medicine – a vital component of making health care shops are operational in medical college hospitals, district, sub-district and
available to all. satellite hospitals by the name of “Life Line Drug Stores” and are operated by
Rajasthan Medicare Relief Societies, which are in fact the “Rogi Kalyan
A dream worth dreaming. Samiti” that is the local hospital management committees. If the state
By Dr Samit Sharma government or local body or charitable trust is ready to bear the cost (which is
very low, about Rs 10 per OPD patient), then these generic drugs can be given
The cost of production of most of the drugs is many times less than the retail to poor/all patients free of cost as is being done by the Government of
price (MRP) printed on it. Generic medicines are not new types of medicines, Rajasthan, through 15,000 free drug distribution Centres, right from medical
these are abundantly available everywhere in India. These are drugs which have college hospital to PHCs and sub-centres. About 400 types of commonly used
come out of the patent duration of 20 years and now, apart from the original essential generic drugs, surgical and sutures are given free of cost in
innovator company, any other pharmaceutical manufacturer can produce this government hospitals in Rajasthan.
salt after getting due permission from the drug control authorities. In fact, 97%
of the drugs in the Indian market are generics (or branded generics). But even The above steps are merely indicative and general guidelines, and they should
these are sold at high prices, because they are prescribed by doctors and be modified according to the circumstances in the field..
supplied by manufacturers under brand names. Branding limits the choice for
the patient, kills competition and creates artificial monopoly, and enables the Dr. Samit Sharma, MD (Paediatrics), I.A.S., is Managing Director of the
manufacturers to charge a very high MRP. Rajasthan Medical Services Corporation, Gandhi Block, Swasthya Bhawan,
The doctor plays a key role not only in prescribing drugs by generic name but Tilak Marg, C-Scheme, Jaipur (Rajasthan) 302 005
also in convincing the patients that these drugs are 100% identical to
commonly used brands in quality, ie, they have the same identity, purity, I am a bit of a dreamer. And that's one of the reasons I am able to do this show. I
strength, bioequivalence and effectiveness, provided the doctor himself is dream that one day we will be living in a country where things will be different. I
convinced of these facts. Even when you open a low-cost generic drug shop the dream that one day, in our country, the rich and the poor will both get the same
patient won't get the price benefit unless the doctor is inclined to help him.The good quality health care. To many it may seem like a totally impractical, and an
patient must also be made to understand that although he is getting a particular unachievable dream… but it's a dream worth dreaming… and one that has
drug at a very low price compared to the printed MRP or his doctor's favourite every reason to come true!. Irrespective of whether you are rich or poor, when
brand, it is in no way different or inferior. It will have the same effect. you lose a loved one, the pain is the same. To watch my child suffer and die while
I am unable to do anything because of an incurable disease is truly sad. But, if
Steps To Open & Operate A Fair Price Generic Medicine Shop there is treatment available which can save my child, but I am unable to save
my child because I can't afford it… and can only helplessly sit by and watch my
The hospital management or the local self-government or NGO or any other
13

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